Granted Patent B2

US 12,697,347 · App. 18/250,674 · Granted Aug 4, 2026

Inventors: Kim-Hien Dao (Pleasanton, CA); Harold Keer (Pleasanton, CA); Aram Oganesian (Pleasanton, CA)

Assignee: Taiho Pharmaceutical Co., Ltd.

A61K31/7068A61K9/0053A61K31/635A61K31/706A61P35/02

Abstract

Claims (16)

1 . A method of treating cancer selected from hematological cancers and solid cancers in a subject in need thereof, comprising administering to the subject an effective amount of cedazuridine, an effective amount of decitabine, and an effective amount of venetoclax, wherein the effective amount of cedazuridine, the effective amount of decitabine, and the effective amount of venetoclax are each administered as an oral dosage form, thereby treating the cancer in the subject.

2 . The method of claim 1 , wherein the hematological cancer is selected from at least one of myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN), leukemia, and lymphoma.

3 . The method of claim 2 , wherein the leukemia is ALL, AML, CML, MPN, or CMML.

4 . The method of claim 3 , wherein the leukemia is AML.

5 . The method of claim 1 , wherein the subject is aged 75 years or older.

6 . The method of claim 1 , wherein the subject has comorbidities that preclude the use of standard induction chemotherapy.

7 . The method of claim 1 , wherein the effective amount of cedazuridine, the effective amount of decitabine, and the effective amount of venetoclax are administered simultaneously, sequentially, or separately.

8 . The method of claim 1 , wherein each oral dosage form is a solid oral dosage form.

9 . The method of claim 8 , wherein the effective amount of cedazuridine and the effective amount of decitabine are administered together in a combination solid oral dosage form.

10 . The method of claim 1 , wherein the effective amount of cedazuridine and the effective amount of decitabine are administered on days 1-5 of a 28-day cycle, and the effective amount of venetoclax is administered each day of the 28-day cycle.

11 . The method of claim 1 , wherein the effective amount of cedazuridine and the effective amount of the decitabine are present in a first solid oral dosage form that comprises 100 mg cedazuridine, 35 mg decitabine, and at least one pharmaceutically acceptable excipient, and wherein the effective amount of venetoclax is present in at least one second solid oral dosage form that comprises 50 mg or 100 mg of venetoclax and at least one pharmaceutically acceptable excipient.

12 . The method of claim 1 , wherein the subject is administered an effective amount of cedazuridine, an effective amount of decitabine, and 100 mg of venetoclax on day 1 of a cycle; an effective amount of cedazuridine, an effective amount of decitabine, and 200 mg of venetoclax on day 2 of the cycle; an effective amount of cedazuridine, an effective amount of decitabine, and 400 mg of venetoclax on days 3-5 of the cycle; and 400 mg of venetoclax on days 6-28 of the cycle.

13 . The method of claim 1 , wherein the subject is administered an effective amount of cedazuridine, an effective amount of decitabine, and 400 mg of venetoclax on days 1-5 of a cycle, and 400 mg of venetoclax on days 6-28 of the cycle.

14 . An oral dosage form comprising cedazuridine, decitabine, and venetoclax, and at least one pharmaceutically acceptable excipient.

15 . The oral dosage form of claim 14 , wherein the oral dosage form is a solid oral dosage form.

16 . The method of claim 6 , wherein the comorbidities are one or more selected from the group consisting of (i) severe cardiac disorder, (ii) severe pulmonary disorder, (iii) creatinine clearance greater than or equal to 30 mL/min and less than 45 mL/min, and (iv) moderate hepatic impairment with total bilirubin greater than 1.5 and less than or equal to 3.0× the upper limit of normal (ULN).

Assignments (3)

Continuity (2)

References Cited (67)